Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/12/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2021 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/23/2021 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/04/2019 | SUPPL-19 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/04/2019 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/04/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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10/13/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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10/13/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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05/06/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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10/12/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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06/27/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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06/27/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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11/28/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
TACROLIMUS
CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGRAF | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | AJENAT PHARMS |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGRAF | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | AJENAT PHARMS |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGRAF | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | AJENAT PHARMS |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |